The RENAAL Study Investigation
- Meeta Sharma, Reviewed by, MD
STUDY
SUMMARY
Design. An investigator-initiated, multicenter, double-blind, randomized, placebo-controlled study. Patients with type 2 diabetes and advanced renal disease were enrolled in a trial comparing losartan (Cozaar), 50–100 mg once daily, with placebo, both taken in addition to conventional antihypertensive treatment (calcium-channel antagonists, diuretics, α-blockers, β-blockers, and centrally acting agents), for a mean of 3.4 years.
Subjects. A total of 1,513 patients were enrolled from 250 centers in 28 countries in Asia, Europe, Central America, South America, and North America.
Primary hypothesis. Long-term treatment with losartan versus placebo (alone or in combination with conventional therapy not including angiotensin-converting enzyme [ACE] inhibition) in type 2 diabetic patients with nephropathy will increase the time to first event and decrease the incidence of doubling of serum creatinine, end-stage renal disease (ESRD), or death.
Secondary hypotheses. Losartan compared to placebo (alone or in combination with conventional non-ACE– inhibitor therapy) in patients with type 2 diabetes and nephropathy will increase the time to first event and decrease the incidence of cardiovascular morbidity and mortality, reduce proteinuria, and decrease the rate of progression of renal disease.
Results. Losartan treatment was associated with:
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28% risk reduction of ESRD over a mean of 3.4 years (P = 0.002)
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25% risk reduction of a doubling of the serum creatinine concentration (P = 0.006)
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35% decrease in the level of proteinuria (P < 0.001)
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32% risk reduction in the …
